Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: SubstanceDefinition (ePI)

Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/SubstanceDefinition-uv-epi Version: 0.1.0
Active as of 2022-09-02 Computable Name: SubstanceDefinitionUvEpi

SubstanceDefinition (ePI)

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from SubstanceDefinition

Summary

Structures

This structure refers to these other structures:

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..*SubstanceDefinitionThe detailed description of a substance, typically at a level beyond what is used for prescribing
... identifier 0..*IdentifierAn identifier or code by which the SubstanceDefinition can be referenced.
... status 0..1CodeableConceptdraft|active|retired|unknown
... classification 0..*CodeableConceptA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity.
... description 0..1markdownTextual description of the substance.
... manufacturer 0..*Reference(Organization (ePI))A company that makes this substance
... moiety 0..*BackboneElementMoiety, for structural modifications.
... molecularWeight 0..*BackboneElementThe molecular weight or weight range.
... structure 0..1BackboneElementStructural information.
... code 0..*BackboneElementCodes associated with the substance.
... name 0..*BackboneElementNames applicable to this substance.
.... name 1..1stringThe actual name.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..*SubstanceDefinitionThe detailed description of a substance, typically at a level beyond what is used for prescribing
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierAn identifier or code by which the SubstanceDefinition can be referenced.
... version Σ0..1stringA business level identifier of the substance
... status Σ0..1CodeableConceptdraft|active|retired|unknown
... classification Σ0..*CodeableConceptA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity.
... domain Σ0..1CodeableConceptIf the substance applies to only human or veterinary use
Binding: MedicinalProductDomain (preferred)
... grade Σ0..*CodeableConceptThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard)
... description Σ0..1markdownTextual description of the substance.
... informationSource Σ0..*Reference(Citation)Supporting literature
... note Σ0..*AnnotationTextual comment about the substance's catalogue or registry record
... manufacturer Σ0..*Reference(Organization (ePI))A company that makes this substance
... supplier Σ0..*Reference(Organization)A company that supplies this substance
... moiety Σ0..*BackboneElementMoiety, for structural modifications.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1CodeableConceptRole that the moiety is playing
.... identifier Σ0..1IdentifierIdentifier by which this moiety substance is known
.... name Σ0..1stringTextual name for this moiety substance
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
.... opticalActivity Σ0..1CodeableConceptOptical activity type
.... molecularFormula Σ0..1stringMolecular formula for this moiety of this substance, typically using the Hill system
.... amount[x] Σ0..1Quantitative value for this moiety
..... amountQuantityQuantity
..... amountStringstring
.... amountType Σ0..1CodeableConceptThe measurement type of the quantitative value
... property Σ0..*BackboneElementGeneral specifications for this substance
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
... referenceInformation Σ0..1Reference(SubstanceReferenceInformation)General information detailing this substance
... molecularWeight Σ0..*BackboneElementThe molecular weight or weight range.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... method Σ0..1CodeableConceptThe method by which the molecular weight was determined
.... type Σ0..1CodeableConceptType of molecular weight such as exact, average (also known as. number average), weight average
.... amount Σ1..1QuantityUsed to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field
... structure Σ0..1BackboneElementStructural information.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
.... opticalActivity Σ0..1CodeableConceptOptical activity type
.... molecularFormula Σ0..1stringMolecular formula of this substance, typically using the Hill system
.... molecularFormulaByMoiety Σ0..1stringSpecified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot
.... molecularWeight Σ0..1See molecularWeight (SubstanceDefinition)The molecular weight or weight range (for proteins, polymers or nucleic acids)
.... technique Σ0..*CodeableConceptThe method used to elucidate the structure or characterization of the drug substance. Examples: X-ray, HPLC, NMR, Peptide mapping, Ligand binding assay
.... sourceDocument Σ0..*Reference(DocumentReference)Supporting literature about the source of information
.... representation Σ0..*BackboneElementA depiction of the structure or characterization of the substance
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ0..1CodeableConceptThe kind of structural representation (e.g. full, partial)
..... representation Σ0..1stringThe structural representation or characterization as a text string in a standard format
..... format Σ0..1CodeableConceptThe format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document
..... document Σ0..1Reference(DocumentReference)An attached file with the structural representation or characterization e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file
... code Σ0..*BackboneElementCodes associated with the substance.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ0..1CodeableConceptThe specific code
.... status Σ0..1CodeableConceptStatus of the code assignment, for example 'provisional', 'approved'
.... statusDate Σ0..1dateTimeThe date at which the code status is changed as part of the terminology maintenance
.... note Σ0..*AnnotationAny comment can be provided in this field, if necessary
.... source Σ0..*Reference(DocumentReference)Supporting literature
... name Σ0..*BackboneElementNames applicable to this substance.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name Σ1..1stringThe actual name.
.... type Σ0..1CodeableConceptName type, for example 'systematic', 'scientific, 'brand'
.... status Σ0..1CodeableConceptThe status of the name, for example 'current', 'proposed'
.... preferred Σ0..1booleanIf this is the preferred name for this substance
.... language Σ0..*CodeableConceptHuman language that the name is written in
.... domain Σ0..*CodeableConceptThe use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive
.... jurisdiction Σ0..*CodeableConceptThe jurisdiction where this name applies
.... synonym Σ0..*See name (SubstanceDefinition)A synonym of this particular name, by which the substance is also known
.... translation Σ0..*See name (SubstanceDefinition)A translation for this name into another human language
.... official Σ0..*BackboneElementDetails of the official nature of this name
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... authority Σ0..1CodeableConceptWhich authority uses this official name
..... status Σ0..1CodeableConceptThe status of the official name, for example 'provisional', 'approved'
..... date Σ0..1dateTimeDate of official name change
.... source Σ0..*Reference(DocumentReference)Supporting literature
... relationship Σ0..*BackboneElementA link between this substance and another, with details of the relationship
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ0..1A pointer to another substance, as a resource or just a representational code
..... substanceDefinitionReferenceReference(SubstanceDefinition)
..... substanceDefinitionCodeableConceptCodeableConcept
.... type Σ1..1CodeableConceptFor example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of"
.... isDefining Σ0..1booleanFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships
.... amount[x] Σ0..1A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other
..... amountQuantityQuantity
..... amountRatioRatio
..... amountStringstring
.... amountRatioHighLimit Σ0..1RatioFor use when the numeric has an uncertain range
.... amountType Σ0..1CodeableConceptAn operator for the amount, for example "average", "approximately", "less than"
.... source Σ0..*Reference(DocumentReference)Supporting literature
... nucleicAcid Σ0..1Reference(SubstanceNucleicAcid)Data items specific to nucleic acids
... polymer Σ0..1Reference(SubstancePolymer)Data items specific to polymers
... protein Σ0..1Reference(SubstanceProtein)Data items specific to proteins
... sourceMaterial Σ0..1BackboneElementMaterial or taxonomic/anatomical source for the substance
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptA classification that provides the origin of the raw material. Example: cat hair would be an Animal source type
.... genus Σ0..1CodeableConceptThe genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name
.... species Σ0..1CodeableConceptThe species of an organism, typically referring to the Latin epithet of the species of the plant/animal
.... part Σ0..1CodeableConceptAn anatomical origin of the source material within an organism
.... countryOfOrigin Σ0..*CodeableConceptThe country or countries where the material is harvested

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..*SubstanceDefinitionThe detailed description of a substance, typically at a level beyond what is used for prescribing

doco Documentation for this format

This structure is derived from SubstanceDefinition

Summary

Structures

This structure refers to these other structures:

Differential View

This structure is derived from SubstanceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..*SubstanceDefinitionThe detailed description of a substance, typically at a level beyond what is used for prescribing
... identifier 0..*IdentifierAn identifier or code by which the SubstanceDefinition can be referenced.
... status 0..1CodeableConceptdraft|active|retired|unknown
... classification 0..*CodeableConceptA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity.
... description 0..1markdownTextual description of the substance.
... manufacturer 0..*Reference(Organization (ePI))A company that makes this substance
... moiety 0..*BackboneElementMoiety, for structural modifications.
... molecularWeight 0..*BackboneElementThe molecular weight or weight range.
... structure 0..1BackboneElementStructural information.
... code 0..*BackboneElementCodes associated with the substance.
... name 0..*BackboneElementNames applicable to this substance.
.... name 1..1stringThe actual name.

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition 0..*SubstanceDefinitionThe detailed description of a substance, typically at a level beyond what is used for prescribing
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierAn identifier or code by which the SubstanceDefinition can be referenced.
... version Σ0..1stringA business level identifier of the substance
... status Σ0..1CodeableConceptdraft|active|retired|unknown
... classification Σ0..*CodeableConceptA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity.
... domain Σ0..1CodeableConceptIf the substance applies to only human or veterinary use
Binding: MedicinalProductDomain (preferred)
... grade Σ0..*CodeableConceptThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard)
... description Σ0..1markdownTextual description of the substance.
... informationSource Σ0..*Reference(Citation)Supporting literature
... note Σ0..*AnnotationTextual comment about the substance's catalogue or registry record
... manufacturer Σ0..*Reference(Organization (ePI))A company that makes this substance
... supplier Σ0..*Reference(Organization)A company that supplies this substance
... moiety Σ0..*BackboneElementMoiety, for structural modifications.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1CodeableConceptRole that the moiety is playing
.... identifier Σ0..1IdentifierIdentifier by which this moiety substance is known
.... name Σ0..1stringTextual name for this moiety substance
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
.... opticalActivity Σ0..1CodeableConceptOptical activity type
.... molecularFormula Σ0..1stringMolecular formula for this moiety of this substance, typically using the Hill system
.... amount[x] Σ0..1Quantitative value for this moiety
..... amountQuantityQuantity
..... amountStringstring
.... amountType Σ0..1CodeableConceptThe measurement type of the quantitative value
... property Σ0..*BackboneElementGeneral specifications for this substance
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
... referenceInformation Σ0..1Reference(SubstanceReferenceInformation)General information detailing this substance
... molecularWeight Σ0..*BackboneElementThe molecular weight or weight range.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... method Σ0..1CodeableConceptThe method by which the molecular weight was determined
.... type Σ0..1CodeableConceptType of molecular weight such as exact, average (also known as. number average), weight average
.... amount Σ1..1QuantityUsed to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field
... structure Σ0..1BackboneElementStructural information.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
.... opticalActivity Σ0..1CodeableConceptOptical activity type
.... molecularFormula Σ0..1stringMolecular formula of this substance, typically using the Hill system
.... molecularFormulaByMoiety Σ0..1stringSpecified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot
.... molecularWeight Σ0..1See molecularWeight (SubstanceDefinition)The molecular weight or weight range (for proteins, polymers or nucleic acids)
.... technique Σ0..*CodeableConceptThe method used to elucidate the structure or characterization of the drug substance. Examples: X-ray, HPLC, NMR, Peptide mapping, Ligand binding assay
.... sourceDocument Σ0..*Reference(DocumentReference)Supporting literature about the source of information
.... representation Σ0..*BackboneElementA depiction of the structure or characterization of the substance
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ0..1CodeableConceptThe kind of structural representation (e.g. full, partial)
..... representation Σ0..1stringThe structural representation or characterization as a text string in a standard format
..... format Σ0..1CodeableConceptThe format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document
..... document Σ0..1Reference(DocumentReference)An attached file with the structural representation or characterization e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file
... code Σ0..*BackboneElementCodes associated with the substance.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ0..1CodeableConceptThe specific code
.... status Σ0..1CodeableConceptStatus of the code assignment, for example 'provisional', 'approved'
.... statusDate Σ0..1dateTimeThe date at which the code status is changed as part of the terminology maintenance
.... note Σ0..*AnnotationAny comment can be provided in this field, if necessary
.... source Σ0..*Reference(DocumentReference)Supporting literature
... name Σ0..*BackboneElementNames applicable to this substance.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name Σ1..1stringThe actual name.
.... type Σ0..1CodeableConceptName type, for example 'systematic', 'scientific, 'brand'
.... status Σ0..1CodeableConceptThe status of the name, for example 'current', 'proposed'
.... preferred Σ0..1booleanIf this is the preferred name for this substance
.... language Σ0..*CodeableConceptHuman language that the name is written in
.... domain Σ0..*CodeableConceptThe use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive
.... jurisdiction Σ0..*CodeableConceptThe jurisdiction where this name applies
.... synonym Σ0..*See name (SubstanceDefinition)A synonym of this particular name, by which the substance is also known
.... translation Σ0..*See name (SubstanceDefinition)A translation for this name into another human language
.... official Σ0..*BackboneElementDetails of the official nature of this name
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... authority Σ0..1CodeableConceptWhich authority uses this official name
..... status Σ0..1CodeableConceptThe status of the official name, for example 'provisional', 'approved'
..... date Σ0..1dateTimeDate of official name change
.... source Σ0..*Reference(DocumentReference)Supporting literature
... relationship Σ0..*BackboneElementA link between this substance and another, with details of the relationship
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... substanceDefinition[x] Σ0..1A pointer to another substance, as a resource or just a representational code
..... substanceDefinitionReferenceReference(SubstanceDefinition)
..... substanceDefinitionCodeableConceptCodeableConcept
.... type Σ1..1CodeableConceptFor example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of"
.... isDefining Σ0..1booleanFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships
.... amount[x] Σ0..1A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other
..... amountQuantityQuantity
..... amountRatioRatio
..... amountStringstring
.... amountRatioHighLimit Σ0..1RatioFor use when the numeric has an uncertain range
.... amountType Σ0..1CodeableConceptAn operator for the amount, for example "average", "approximately", "less than"
.... source Σ0..*Reference(DocumentReference)Supporting literature
... nucleicAcid Σ0..1Reference(SubstanceNucleicAcid)Data items specific to nucleic acids
... polymer Σ0..1Reference(SubstancePolymer)Data items specific to polymers
... protein Σ0..1Reference(SubstanceProtein)Data items specific to proteins
... sourceMaterial Σ0..1BackboneElementMaterial or taxonomic/anatomical source for the substance
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptA classification that provides the origin of the raw material. Example: cat hair would be an Animal source type
.... genus Σ0..1CodeableConceptThe genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name
.... species Σ0..1CodeableConceptThe species of an organism, typically referring to the Latin epithet of the species of the plant/animal
.... part Σ0..1CodeableConceptAn anatomical origin of the source material within an organism
.... countryOfOrigin Σ0..*CodeableConceptThe country or countries where the material is harvested

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
SubstanceDefinition.languagepreferredCommonLanguages
Max Binding: AllLanguages
SubstanceDefinition.domainpreferredMedicinalProductDomain